ABSTRACT
Objective To identify major factors which affect the completion quality of projects and build predictive models,and to propose strategies and suggestions for total process quality management of clinical research projects of the hospital.Methods Collect relevant literatures from home and abroad;consult completion reports of various research projects completed from 2003 to 2010 and sum up problems found in such projects.Carry out in-depth interviews with principal investigators,supervisors of scientific research of the hospital as well as administrators of sponsor institutions.A questionnaire survey was made on completed clinical research projects undertaken from 2003 to 2010.Results Six key factors affecting implementation of such projects were derived from factor analysis,which are research technology and external environment,project teamwork,research subject availability,project organization,manpower input,and research design.A multiple logistic regression analysis found project internal management and manpower input as two leading predictive factors for project completion outcomes,while the former has a greater impact than the latter.Conclusion Project management should focus on the 6 key factors affecting project quality.The two main predictive factors should attract greater attention and resources in both supervision and management.